Validation of Receptor Occupancy Simulation

Schizophrenia Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01660880
• Other study ID #: C-1205-094-410
• Secondary ID: A070001
• Status: Completed
• Start date: December 2012
• Est. completion date: April 2014

Study information

• Verified date: April 2019
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

• To estimate dopamine receptor occupancy by aripiprazole using computer simulation

• To measure dopamine receptor occupancy by aripiprazole in patients treated with the antipsychotics

• To validate the simulation result by comparing the receptor occupancy from the simulation with that from the patients

Recruitment information / eligibility

• Status: Completed
• Enrollment: 7
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years to 55 Years

Eligibility

Inclusion Criteria:

• clinical diagnosis of schizophrenia

• treated with aripiprazole or risperidone

• no change in dose of antipsychotics for at least 6 weeks

• total PANSS score should be below 80

Exclusion Criteria:

• Other psychiatric disorders rather than schizophrenia

• history of head trauma

• positive in urine hCG

• on antidepressant, anticholinergics or mood stabilizer

Related Conditions & MeSH terms

• Dopamine Receptor Occupancy
• Medication Satisfaction
• Prolactin Level
• Schizophrenia

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Dopamine receptor occupancy	Measured using 11C-raclopride positron emission tomography	72 hrs after the last administration
Secondary	Hamilton rating scale for depression	HAM-D score	Baseline and 72 hours after the last administration
Secondary	Barnes akathisia scale	BAS score	Baseline and 72 hours after the last administration
Secondary	Abnormal involuntary movement scale	AIMS score	Baseline and 72 hours after the last administration
Secondary	Simpson-Angus scale	SAS score	Baseline and 72 hours after the last administration
Secondary	Treatment satisfaction questionnaire for medication	TSQM score	Baseline and 72 hours after the last administration
Secondary	Medication satisfaction questionnaire	MSQ score	Baseline and 72 hours after the last administration
Secondary	N-back task	To measure the change in working memory performance	Baseline and 72 hours after the last administration
Secondary	Prolactin level	To explore the effect of receptor occupancy on the blood prolactin level	Baseline and 72 hours after the last administration
Secondary	Dopamine receptor occupancy		3 hrs after the last administration
Secondary	Dopamine receptor occupancy		24 hrs after the last administration